Senior Quality Engineer for Non-AMD

Job description

Senior Quality Engineer for Non-Active Medical Devices At Fresenius Medical Care , we are the global leader in kidney care, committed to improving the lives of patients with chronic kidney disease. Our mission is to deliver high-quality, innovative products, services, and care across the entire healthcare journey. Guided by our vision—“Creating a future worth living. For patients. Worldwide. Every day.”—we work with purpose and compassion, supported by a global team of over 110,000 employees. Within our Care Enablement segment, we develop and provide life-sustaining medical products, digital health solutions, and therapies that empower clinical teams and improve patient outcomes. Our FME Reignite strategy drives transformation through innovation, efficiency, and sustainable growth. Our values guide how we work: We Care for our patients, each other, and our communities We Connect across teams and borders to deliver excellence together We Commit to doing things the right way—growing with purpose and leading kidney care with integrity and innovation At our Reynosa plant in Mexico, we are committed to the highest standards in the production of disposable medical products for dialysis treatments. With a dedicated team of more than 3,000 employees across four manufacturing sites, the plant focuses on manufacturing essential components such as hemodialysis disposables, peritoneal dialysis (PD) disposables, hemodialysis (HD) machines, and PD cycler machines. By utilizing advanced technologies to ensure the highest standards in dialysis product manufacturing, we’re not only driving innovation—we’re also creating meaningful change for patients worldwide. Join our passionate team and be part of this global impact. As a Senior Quality Engineer for Non-Active Medical Devices (NAMD), you will be responsible for ensuring product and manufacturing process quality by providing advanced manufacturing quality engineering expertise. You will act as a technical Subject Matter Expert (SME), supporting complex and systemic quality investigations, CAPA and nonconformance resolution, design transfer, validation, risk management, and continuous improvement activities. Your Responsibilities: Act as a technical Subject Matter Expert (SME) in Manufacturing Quality Engineering for Non-Active Medical Devices (NAMD). Analyze manufacturing quality trends, process capability data, and defect patterns to identify systemic issues affecting product performance or reliability. Lead technical walkthroughs and quality risk assessments within manufacturing areas to proactively identify quality risks and improvement opportunities. Provide technical leadership to cross-functional teams addressing complex manufacturing quality challenges. Lead complex root cause investigations involving escalated CAPAs, recurring manufacturing defects, significant nonconformances, and field complaints linked to manufacturing processes. Drive structured problem-solving activities using methodologies such as 8D, DMAIC, statistical analysis, and failure analysis techniques. Evaluate CAPA effectiveness through trend analysis and process performance monitoring. Provide technical leadership during design transfer activities, ensuring manufacturing readiness and process capability. Participate in design reviews, risk assessments, and engineering change evaluations impacting manufacturing quality. Review and approve relevant technical documentation, including drawings, specifications, test methods, and risk analyses. Lead or technically support process validation, Test Method Validation (TMV), equipment qualification, and Measurement System Analysis (MSA). Ensure validation activities comply with regulatory and quality system requirements. Identify systemic manufacturing quality issues and lead improvement initiatives focused on product reliability, reduction of Cost of Poor Quality, and manufacturing process capability. Lead or support manufacturing risk management activities, including PFMEA development and updates. Evaluate risks associated with manufacturing processes, engineering changes, and quality investigations. Provide technical expertise during internal and external audits related to manufacturing quality investigations and systemic quality issues. Ensure engineering-driven quality activities support compliance with ISO 13485, FDA 21 CFR Part 820, and MDSAP. Collaborate closely with Manufacturing Engineering, Product Engineering/R&D, Operations, and Supplier Quality, including cross-site investigations when advanced technical expertise is required. Your Profile Bachelor’s Degree in Electronic, Mechanical, Industrial Engineering, or a related engineering field. 3–5 years of experience in Quality Engineering or Manufacturing Engineering within regulated medical device and manufacturing environments, preferably involving Non-Active Medical Devices (NAMD) or manufacturing processes of comparable complexity. Demonstrated experience leading complex manufacturing quality investigations. Experience with CAPA and systemic quality issue resolution. Experience with design transfer activities from R&D to Manufacturing. Experience with manufacturing risk assessments and PFMEA. Experience with process capability and statistical data analysis. Experience with process validation and Test Method Validation (TMV). Knowledge of Statistical Process Control (SPC), Measurement System Analysis (MSA), Design of Experiments (DOE), ANOVA, and probability analysis. Experience with Lean Manufacturing and Six Sigma tools. Strong knowledge of medical device quality systems, including ISO 13485, FDA 21 CFR Part 820, and MDSAP. Experience with supplier quality management and CAPA systems. Advanced English U.S. Visa required. Intermediate/advanced proficiency in Microsoft Office, statistical software (Minitab preferred), ERP/MES, and Quality Management Systems. Preferred certifications: Lead Auditor, Certified Quality Engineer (CQE), and Six Sigma Green Belt or Black Belt. Strong technical leadership, decision-making, technical presentation, and cross-functional communication skills. Our Offer for You There is a lot you can discover at Fresenius Medical Care, regardless of the field of expertise or level of experience—everything is dedicated to supporting your professional journey. • Whether in front of or behind the scenes, you help make better medicine available to more people worldwide • Individual opportunities for self‑determined career planning and professional development • A corporate culture that encourages innovative thinking—finding the best solution together, not just the fastest one • A team of committed professionals with diverse skills, talents, and experiences • The strength of a successful global corporation combined with the collegial culture of a mid‑sized company.